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GMED at The MedTech Forum 2024

Meet our team at The MedTech Forum in Vienna from May 22 to 24, Europe’s leading healthcare and medical technology (...)

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MDCG 2024-4 guidance on safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

The recording and reporting to competent authorities of adverse events occurring during performance studies of in vitro diagnostic medical devices (...)

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1st revision of the MDCG 2022-9 guidance on the template for the Summary of Safety and Performance characteristics under Regulation (EU) 2017/746

Published by the Medical Device Coordination Group (MDCG), the MDCG 2022-9 guidance proposes a template to follow the Summary of (...)

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